1. Field of the Invention
The present invention relates to a method and composition for treatment of hepatitis C virus (HCV), administered as a two component treatment, involving 1) an orally administered SQUALENE, 500 mg twice per day and 2) the inhalation of squalene through the nasal membrane to the blood stream three times per day, 2-to-3 drops (10 to 15 mg.) each time. The period of treatment is two to six months, depending on the quantity of the viral load. The two components are administered concurrently to achieve the best results. Medicinal theoretical study have shown that squalene has the potential of antiviral activity, furthermore, in vitro assay has shown that the squalene compound inhibits the replication of hepatitis C virus and competitive to interferon-.alpha.(IFN). This is beside the use of that treatment on a hepatitis C patient.
2. Description of Prior Art
Chronic infection by hepatitis C virus (HCV) is a global disease and the number of carriers is estimated to be 300 million (reported by Purcell in 1994, Van der Poel in 1994, Love et al. In 1996 and Kim et al. In 1996). Alter and Maste in 1994 reported that four million individuals are in the United States alone. Outside the United States, for example in Egypt, 25% of the Egyptian population is infected. HCV is the major etiologic agent or human parentally and community-acquired non-A, non-B hepatitis (NANBH) (Choo et al. in 1989). Most HCV infections occur by blood transfer, whether by blood transfusion or a contaminated syringes, which is often seen in cases of shared syringes by drug addicts.
20% of the infected individuals develop acute clinical hepatitis (Kim et, al. in 1996). However, in most cases the virus establishes a chronic infection that persists for decades as stated by Iwarson in 1994. The uncertainty of the availability or even the prospects of safe and effective anti-HCV vaccines, made no protection against HCV for many years. The unavailability of HCV diagnostic identification, until it was recently identified by molecular cloning and sequencing around 1989 (Alter et al., Choo et al., Kuo et al.), where technology of the diagnostic test became available to the diagnostic laboratories and the practicing physicians in early 1990's. Prior to that time, chronic HCV infections could have been asymptotic, therefore, making diagnosis of HCV cases by the physician difficult and essentially undetectable until late stage when secondary effects of the infection are noted by the patient, who only then seeks treatment. Moreover, no reported method exists for effective treatment of late stage HCV carriers, with the exception of interferon (IFN) treatment which have significant side effects (Renault et al. In 1989) or liver transplantation, which has unpredictable results in some cases. Even though, the patients who go for liver transplantation and still have HCV in their blood stream still at risk from developing liver cirrhosis and other complications. At present the only accepted medical treatment is the IFN; its positive response is observed in about 50% of the patients with chronic HCV infection and the reduction in the viral load was averaged to 25 to 31% (Statistical data from C&S clinical Laboratories Inc.). Although IFN has shown great promise in a subset of patients treated for a prolonged period of time, these response rates have overall, unfortunately been disappointing, and toxicity to effective doses is substantial. Therefore, the need for an effective treatment to abolish HCV completely from the patient system is necessary.
Because of latent nature of the symptomatology (10 to 15 years) of the infection, the liver may be saved only if the chronic liver disease is not sufficiently advanced. This can be achieved if the HCV replication can be inhibited by the use of certain anti-HCV compound if available. A proportion of those patients will, nevertheless, ultimately develop problems such as cirrhosis, portal hypertension, varices, gastric erosions, ulcers and hepatocellular carcinoma. With this understanding, it is not surprising that late stage HCV carriers are still at increased risk of morbidity and mortality. A review of the patents and medical literature fails to reveal any suggested safe remedies for HCV. However, there are alternative methods for treatment using natural products which is historically known to cure liver and gastric problems (John Gerared, James Duke, and Kee Chang Huang), however, according to the late clinical trial in Egypt (personal communication), where they used undisclosed group of herbs for the treatment of hepatitis C. The analysis of the herbs used have shown to contains some toxic substances, which in unregulated doses can cause serious side effects and makes the use of these herbs as a treatment for HCV dangerous. Such poison constituents include: Pyrogallol, which when ingested, causes gastrointestinal irritation, renal and hepatic damage, hemolysis, methemoglobinemia, convulsion, circulatory collapse and even death; Camphor, which when ingested or injected causes nausea, vomiting, vertigo, mental confusion, delirium, colonic convulsion, coma, respiratory failure and death; and Bis(2-ethylhexyl)Phthalate where the symptoms of its exposure are irritation of eyes and mucous membranes and may reasonably be anticipated to be carcinogen Seventh Annual Report on carcinogens (PB95-109781, 1994) p. 168!. Moreover, case studies of HCV treatment using the undisclosed herbs have been released in which symptoms have been reported suggested the above mentioned poison constituents, and thus suggesting the identity of the herbs.
Medicinal information sources shows that, there are many pharmaceutical preparations for viral hepatitis, however none of them is specific for HCV except the IFN. This could be due to at least three reasons. First: because of the late discovery of the HCV diagnostic test. Second: because of the latent nature of the HCV infections. Third: the receptors or reaction sites were not clear until very recently on October of 1996, when two research groups (Love et al.) in Agouron Pharmaceuticals and (Kim et al.) In Vertex Pharmaceuticals published simultaneously their articles about the possible HCV sites which could be the basis for future efforts for drug design. Recently, the combination of Ribavirin and IFN was introduced as a therapy of chronic hepatitis C (Schvarcz et al.) where a clinical trial was made in four European countries showing shorter period of treatment than IFN alone and a sustained response rate defined as normal alanine aminotransferase (ALT) levels and undetectable HCV RNA in six months after the end of therapy.